PROSTATE SEEDING NEEDLE

K973184 · Promex, Inc. · IWJ · Nov 21, 1997 · Radiology

Device Facts

• Record ID: K973184
• Device Name: PROSTATE SEEDING NEEDLE
• Applicant: Promex, Inc.
• Product Code: IWJ · Radiology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5650
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the manual application of a radionuclide source into the body for radiation therapy.

Device Story

Prostate Seeding Needle is a manual surgical instrument used for the delivery of radionuclide sources into the prostate gland for radiation therapy. The device is operated by a physician in a clinical or surgical setting. It functions as a delivery vehicle for radioactive seeds, allowing for precise placement within the target tissue. The physician manually inserts the needle to the desired location and deploys the radionuclide source. This procedure facilitates localized radiation treatment, potentially improving therapeutic outcomes for patients with prostate conditions requiring brachytherapy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual surgical needle for radionuclide delivery. Class I device (21 CFR 892.5650). No electronic, software, or complex mechanical components described.

Indications for Use

Indicated for the manual application of a radionuclide source into the body for radiation therapy in patients requiring brachytherapy.

Regulatory Classification

Identification

A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Joseph L. Mark Vice President Promex, Inc. 1125 Brookside Ave. Suite G500 Indianapolis, IN 46208 Re:

K973184 Prostate Seeding Needle Dated: August 20, 1997 Received: August 25, 1997 Regulatory class: I 21 CFR 892.5650/Procode: 90 IWJ NOV 2 1 1997

Dear Mr. Mark:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the interest for use stated in the enolesure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA funding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ka73184 5 10(k) Number (if known):

Prostate Seeding Needle Device Name:

Indications For Use:

For the manual application of a radionuclide source into the body for radiation therapy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elmerd C. Seymour

(Division Sign-Off) Division of Reproductive, Abdor .. Ial. ENT. and Radiological Device :((k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

4k-31